Capabilities

End-to-end peptoid CDMO services.

Process development to GMP commercial supply, with the most advanced regulatory program in the category.

03 — Regulatory

The most advanced peptoid program at the FDA.

Most peptoid programs sit in academic preclinical. Ours has moved through the FDA further than any other in the category.

Stage 01
Preclinical

GLP tox package complete.

Cleared
Stage 02
Pre-IND / FDA Type B meeting

Briefing package accepted; meeting held.

Cleared
Stage 03
IND filing / active engagement

Currently under FDA review.

In progress
Stage 04
First-in-human, Phase 1

Sites identified, protocol drafted.

Planned
Stage 05
Phase 2 / 3 / registration

Future development pathway.

Future

Request the regulatory dossier

NDA-gated. Detailed milestone timeline, briefing summaries, and forward plan.

Request access

Let's discuss your peptoid program.

Tell us where you are. We'll send back the right path to scale, the right experts, and the right paperwork.